Adjunctive laser-stimulated stem-cells therapy to primary reperfusion in acute myocardial infarction in humans: Safety and feasibility study.

Background Low-level laser therapy (LLLT) has photobiostimulatory effects on stem cells and may offer cardioprotection. This cell-based therapy may compliment primary percutaneous coronary intervention (PPCI) in patients with ST-segment elevation myocardial infarction (STEMI). Objective In this randomized control trial, our primary objective was to determine the safety and feasibility of LLLT application to the bone marrow in patients with STEMI undergoing PPCI. Methods We randomly assigned patients undergoing PPCI to LLLT or non-laser therapy (NLT). In the LLLT group, 100 s of laser therapy was applied to the tibia bone prior to PPCI, as well as 24 and 72 h post-PPCI. In the control group, the power source was turned off. The primary outcome was the difference in door-to-balloon (D2B) time, and additional outcomes included differences in circulating cell counts, cardiac enzymes, and left-ventricular ejection fraction (LVEF) at pre-specified intervals post-PPCI. Results Twenty-four patients were randomized to LLLT (N = 12) or NLT (N = 12). No adverse effects of the treatment were detected. The D2B time was not significantly different between the groups (41 +/- 8 vs 48 +/- 1 min; P = 0.73). Creatinine Phosphokinase area under the curve, was lower after LLLT (22 +/- 10) compared to NLT (49 +/- 12), but this was not statistically significant (P = 0.08). Troponin-T was significantly lower after LLLT (2.7 +/- 1.4 ng/mL) in comparison to NLT (5.2 +/- 1.8 ng/mL. P < 0.05). At 9 months, LVEF improved in both groups without a significant difference between LLLT (55 +/- 9%) and NLT (52 +/- 9%; P = 0.90). Conclusion LLLT is a safe and feasible adjunctive cell-based therapy to PPCI that may benefit ischemic myocardium.